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Completed

NCT Number: NCT02324985

Phase II Study of AP0302 5% Versus a Vehicle Comparator

This study is designed to evaluate the analgesic safety and efficacy of study drug (AP0302) applied topically every 6 hours as compared to a vehicle, in subjects experiencing delayed onset muscle soreness.

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Key information

Conditions

Pain Delayed Onset Muscle Soreness Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Myalgia Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Lotus Clinical Research, LLC

Pasadena, California, 91105, United States

About this study

The purpose of this study is to evaluate the efficacy and safety of S-Ibuprofen Topical Gel 5% in reducing pain/soreness associated with delayed onset muscle soreness (DOMS).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • no clinically significant medical conditions
  • BMI between 18-30
  • negative drug, alcohol, pregnancy screens
  • other protocol-defined inclusion criteria may apply

Exclusion criteria

  • no upper extremity workout in last 6 months
  • no job requiring heavy lifting
  • history of muscle disorders
  • allergy or intolerance to study drug
  • history of recent pain medication use
  • other protocol-defined exclusion criteria may apply

Treatment and study plan

S-Ibuprofen Topical Gel 5%

Drug

S-Ibuprofen Topical Gel 5% applied every 6 hours

Other names: Active Gel

Vehicle Topical Gel

Drug

Vehicle Topical Gel applied every 6 hours

Other names: Vehicle Gel

Primary outcomes

  1. Sum of pain intensity differences over 24 hours from baseline (SPID24) with movement

    Time frame: 0-24 hours

    SPID 24

Secondary outcomes

  1. Sum of pain intensity differences over 48 hours from baseline (SPID48) with movement

    Time frame: 0-48 hours

    SPID 48movement

  2. Sum of pain intensity differences over 48 hours from baseline (SPID48) at rest

    Time frame: 0-48 hours

    SPID 48rest

Sponsors and collaborators

Lead sponsor

Aponia Laboratories, Inc.

Industry

Registry information

Official study title

Phase II Study of the Effects of AP0302 5% (S-Ibuprofen Topical Gel 5%) Versus the Vehicle Control on Delayed Onset Muscle Soreness of the Elbow Flexors

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Dec 24, 2014
Registry last updated
Feb 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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